The Efficacy of Treadmill Training on Walking and Quality of Life of Adults with Spastic Cerebral Palsy: A Randomized Controlled Trial.

Objectives
We aimed to evaluate the efficacy of treadmill training on walking speed and endurance and quality of life in ambulatory adults with spastic cerebral palsy (CP) versus traditional physiotherapy.


Materials & Methods
Participants (17 men, 13 women; mean (SD) age 25 yr, 9 m (7 yr, 10m) range 18-45) with Gross Motor Function Classification System (GMFCS) levels below IV (I, II, and III) from the Ra'ad Rehabilitation Goodwill Complex, Tehran, Iran randomly were allocated to the experimental and the control groups each with 15 persons in 2014. The training (treadmill for experimental group and conventional physiotherapy for control group) was conducted two times a week for 8 weeks. Statistical analysis was made by Repeated Measures of ANOVA for changes within the group during the time and Independent t and Mann-Whitney U tests for the differences between the groups.


Results
Although the experimental group showed a significant improve in the gait speed [1.08(0.47) m/s to 1.22(0.50) m/s] (P=0.002) and in the gait endurance [291.13(160.28) m to 342.63 (174.62) m] (P=0.002), however the changes of the outcome measures of walking and quality of life the between groups were not significant.


Conclusion
The treadmill training without body weight support would improve walking speed and endurance in adults with spastic CP. It would not be however more effective than the traditional physiotherapy to increase the gait performances and function and the quality of life in adults with CP.


Introduction
Cerebral palsy (CP) is the result of damage to the brain from birth to two years old. However, the clinical signs include spasticity, pain and stiffness, declined mobility and function and gait impairments are deteriorated by aging (1). Overall, 44% of the adults with CP experience deterioration of walking skills before age 35 (2).
The causes of impaired mobility and function in CP patients consists of abnormal walking patterns, spasticity, stiffness, muscle weakness, reduced walking speed and endurance and immobility (3)(4)(5). In adults with CP, limited activities and levels of participation including the social interaction, employment, marriage, education and hobbies in society would reduce their quality of life (6,7). Services provided for adults with physical disabilities are often inadequate, even in developed countries (8). At least, the obvious low preference given to the adults with CP is partially, because the physiotherapists recognized that their attempts are better applied to the young child (9) Treadmill training is one of the functional physical therapy practices based on the task-oriented approaches (10), to improve the gait impairments and also the participation of the patients with neurological disabilities (11)(12)(13) Evidence for the effect of physiotherapy on adolescents and adults with CP is sparse, and therefore there is a need for well-designed physiotherapeutic trials for these people (19). There is no study yet on the effectiveness of treadmill

Participants
The participants were recruited from the Ra'ad Rehabilitation Goodwill Complex, an educational and rehabilitation charity center in the northwest of Tehran, Iran in 2014. The participants were included whose spastic CP was approved by a neurologist, aged between 18-45 yr and had ability to walk with or without auxiliary facilities according to the level I to III of the Gross Motor Function Classification System (GMFCS). This refers to mild to moderate severity of CP so that they would walk with or without the assistive devices (20). They had ability to follow commands and they got a minimum score of 18 from the Mini-Mental State Examination (MMSE) (21). If the people had surgery on the lower limbs or had taken any oral or injectable anti-spasm medicine during the last 6 months, or they had other concurrent orthopedic or neurologic diseases such as Multiple Sclerosis, Alzheimer's, Parkinson's, fractures and soft tissue injuries in the lower limbs, had heart disease or uncontrolled epilepsy, they were excluded from the study.

Procedure
The demographic data and personal information were collected from the patients' records archived in the physiotherapy clinic of the institution.
Before group random allocation, two people from 37 participants were excluded because of traveling, so the number of volunteers diminished to 35.
The participants were stratified according to the severity of the disorder (level I-II or level III of GMFCS), kinds of CP (hemiplegia, diplegia or quadriplegia) and sexuality (male or female) and then randomly allocated into two groups. This process was led by physiotherapists that worked in the institution and were blinded to the intervention.
To assign the participants to the experimental or control groups, sealed envelopes were used.  Before the test, the subjects were warned not to run. Participants were asked to walk with their fastest speed. After about 10 min of rest, the next test was conducted.

Results
Of 35 participants screened and assessed at baseline, 5 patients before the second assessment withdrew from the study because of traveling.
The progression of participation through study process is summarized in Figure 1. There were no significant differences between the two groups for demographic characteristics (age, weight and height) or outcome measures at baseline (P<0.05) ( Table 1).
Of 16 sessions, attending sessions for the control group was 11/8± 2/9 with a minimum of 9 and a maximum of 16, and for the experimental group was 13/9 ± 1/6 with a minimum of 11 and maximum of 16 sessions for two months. No injury involved to anyone in the study due to interventions.
As training intensity increased in control group by adding the repetition of constant weight exercise  Table 2). Between groups difference in any of the outcome measures was not significant (Table 3).     The mean percent of change of walking speed of experimental group in our trial was 22.5% after intervention ( Figure 2). This finding was smaller than the magnitude of change of 68% obtained in a study (16), which included school-aged children with moderate to severe functional disability.
Children with relatively severe walking disabilities can make appreciable changes in performance after participation in a Partial Body Weight Supported Treadmill Training program. This is a logical consequence because the participants in this study were younger than our study.
Another finding of our study was improvement of gait endurance after one month of training for treadmill group and after two months for the control group. Perhaps treadmill training can increase gait endurance earlier.
In the study of treadmill training without partial body weight support versus overground walking, the treadmill group obtained more increase in gait endurance (17). Probably getting more change in gait endurance of the experimental group versus the control group than present study, in addition to the age differences of both trial, is probably due  There are some studies (31,32)  All authors agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.